JP6176849B2 - アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤 - Google Patents

アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤 Download PDF

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Publication number
JP6176849B2
JP6176849B2 JP2013524738A JP2013524738A JP6176849B2 JP 6176849 B2 JP6176849 B2 JP 6176849B2 JP 2013524738 A JP2013524738 A JP 2013524738A JP 2013524738 A JP2013524738 A JP 2013524738A JP 6176849 B2 JP6176849 B2 JP 6176849B2
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antibody
preparation
protein
arginine
present
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JPWO2013012022A1 (ja
Inventor
大介 亀岡
大介 亀岡
誠也 安武
誠也 安武
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Chugai Pharmaceutical Co Ltd
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Chugai Pharmaceutical Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
JP2013524738A 2011-07-19 2012-07-19 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤 Active JP6176849B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2011157654 2011-07-19
JP2011157654 2011-07-19
PCT/JP2012/068276 WO2013012022A1 (ja) 2011-07-19 2012-07-19 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤

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JP2017115935A Division JP6469765B2 (ja) 2011-07-19 2017-06-13 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤

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JPWO2013012022A1 JPWO2013012022A1 (ja) 2015-02-23
JP6176849B2 true JP6176849B2 (ja) 2017-08-09

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JP2017115935A Active JP6469765B2 (ja) 2011-07-19 2017-06-13 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤

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US (2) US9574005B2 (https=)
EP (1) EP2735315B1 (https=)
JP (2) JP6176849B2 (https=)
WO (1) WO2013012022A1 (https=)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013012022A1 (ja) 2011-07-19 2013-01-24 中外製薬株式会社 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤
UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
JP2017502922A (ja) * 2013-10-29 2017-01-26 アルブミディクス アクティーゼルスカブ 抗体組成物
MX2016008498A (es) * 2013-12-27 2016-10-07 Chugai Pharmaceutical Co Ltd Metodo para purificar anticuerpo que tiene bajo punto isoelectrico.
TWI694836B (zh) * 2014-05-16 2020-06-01 英商葛蘭素史克智慧財產管理有限公司 抗體調配物
WO2016065181A1 (en) 2014-10-23 2016-04-28 Amgen Inc. Reducing viscosity of pharmaceutical formulations
AR104050A1 (es) * 2015-03-26 2017-06-21 Chugai Pharmaceutical Co Ltd Proceso de producción con iones de cobre controlados
JP5954916B1 (ja) 2015-04-14 2016-07-20 中外製薬株式会社 Ｉｌ−３１アンタゴニストを有効成分として含有する、アトピー性皮膚炎の予防用及び／又は治療用医薬組成物
TW201726111A (zh) * 2015-09-30 2017-08-01 持田製藥股份有限公司 含高濃度抗體之液體製劑
MA43734A (fr) 2016-03-03 2018-11-28 Regeneron Pharma Procédés de traitement de patients atteints d'hyperlipidémie par administration d'un inhibiteur de pcsk9 en combinaison avec un inhibiteur d'angptl3
JP7377596B2 (ja) 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法
SI4190355T1 (sl) 2017-04-28 2025-02-28 Amgen Inc. Formulacije humanih protiteles proti-RANKL in postopki njihove uporabe
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
JP7382232B2 (ja) 2017-05-02 2023-11-16 メルク・シャープ・アンド・ドーム・エルエルシー 抗ｌａｇ３抗体の製剤および抗ｌａｇ３抗体と抗ｐｄ－１抗体との共製剤
DK4364724T3 (da) 2018-05-10 2025-12-22 Regeneron Pharma Formuleringer med høj koncentration af VEGF-receptorfusionsprotein
WO2020081408A1 (en) 2018-10-18 2020-04-23 Merck Sharp & Dohme Corp. Formulations of anti-rsv antibodies and methods of use thereof
MX2021004928A (es) 2018-10-31 2021-06-08 Merck Sharp & Dohme Llc Cristales de anticuerpo anti-pd-1 humano y metodos de uso de los mismos.
EP3876990A4 (en) 2018-11-07 2023-09-06 Merck Sharp & Dohme LLC CO-FORMULATIONS OF ANTI-LAG3 ANTIBODIES AND ANTI-PD-1 ANTIBODIES
US12559551B2 (en) * 2019-05-24 2026-02-24 Regeneron Pharmaceuticals, Inc. Stabilized formulations containing anti-ANGPTL3 antibodies
EP3763356A1 (en) * 2019-07-12 2021-01-13 Ludwig-Maximilians-Universität München Excipient for biotherapeutics
MX2022005654A (es) 2019-11-20 2022-06-22 Chugai Pharmaceutical Co Ltd Preparacion que contiene anticuerpo.
JP2025078889A (ja) * 2022-02-03 2025-05-21 天野エンザイム株式会社 酵素製剤
TW202602486A (zh) 2024-03-07 2026-01-16 瑞士商Ｃｓｌ貝林股份有限公司 免疫球蛋白組成物及產生氣溶膠之方法

Family Cites Families (50)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS58201994A (ja) 1982-05-21 1983-11-25 Hideaki Hagiwara 抗原特異的ヒト免疫グロブリンの生産方法
JPS6013718A (ja) 1983-07-05 1985-01-24 Chemo Sero Therapeut Res Inst Ｂ型肝炎ワクチン
JPS60193925A (ja) 1984-03-13 1985-10-02 Chemo Sero Therapeut Res Inst 凍結乾燥製剤化ワクチン
US4597966A (en) 1985-01-09 1986-07-01 Ortho Diagnostic Systems, Inc. Histidine stabilized immunoglobulin and method of preparation
GB8607679D0 (en) 1986-03-27 1986-04-30 Winter G P Recombinant dna product
WO1996033735A1 (en) 1995-04-27 1996-10-31 Abgenix, Inc. Human antibodies derived from immunized xenomice
DK0585287T3 (da) 1990-07-10 2000-04-17 Cambridge Antibody Tech Fremgangsmåde til fremstilling af specifikke bindingsparelementer
GB9015198D0 (en) 1990-07-10 1990-08-29 Brien Caroline J O Binding substance
ATE158021T1 (de) 1990-08-29 1997-09-15 Genpharm Int Produktion und nützung nicht-menschliche transgentiere zur produktion heterologe antikörper
WO1993012227A1 (en) 1991-12-17 1993-06-24 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
US5795965A (en) 1991-04-25 1998-08-18 Chugai Seiyaku Kabushiki Kaisha Reshaped human to human interleukin-6 receptor
EP0605522B1 (en) 1991-09-23 1999-06-23 Medical Research Council Methods for the production of humanized antibodies
PT1024191E (pt) 1991-12-02 2008-12-22 Medical Res Council Produção de auto-anticorpos a partir de reportórios de segmentos de anticorpo e exibidos em fagos
JP2942412B2 (ja) 1991-12-26 1999-08-30 鐘紡株式会社 化粧料
CA2131151A1 (en) 1992-03-24 1994-09-30 Kevin S. Johnson Methods for producing members of specific binding pairs
ES2301158T3 (es) 1992-07-24 2008-06-16 Amgen Fremont Inc. Produccion de anticuerpos xenogenicos.
JPH08509612A (ja) 1993-04-26 1996-10-15 ジェンファーム インターナショナル インコーポレイテッド 異種抗体を産生することができるトランスジェニック非ヒト動物
GB9313509D0 (en) 1993-06-30 1993-08-11 Medical Res Council Chemisynthetic libraries
WO1995015388A1 (en) 1993-12-03 1995-06-08 Medical Research Council Recombinant binding proteins and peptides
DE69535243T2 (de) 1994-07-13 2007-05-10 Chugai Seiyaku K.K. Gegen menschliches interleukin-8 gerichteter, rekonstituierter menschlicher antikörper
WO1996034096A1 (en) 1995-04-28 1996-10-31 Abgenix, Inc. Human antibodies derived from immunized xenomice
ES2434840T3 (es) 1995-07-27 2013-12-17 Genentech, Inc. Formulación de proteína liofilizada isotónica estable
EP0962467A4 (en) 1996-09-26 2002-10-30 Chugai Pharmaceutical Co Ltd Antibody against human parathormone related peptides
UA76934C2 (en) 1996-10-04 2006-10-16 Chugai Pharmaceutical Co Ltd Reconstructed human anti-hm 1.24 antibody, coding dna, vector, host cell, method for production of reconstructed human antibody, pharmaceutical composition and drug for treating myeloma containing reconstructed human anti-hm 1.24 antibody
DK1069185T3 (da) 1998-04-03 2011-06-27 Chugai Pharmaceutical Co Ltd Humaniseret antistof mod human vævsfaktor (TF) og fremgangsmåde til at konstruere humaniseret antistof
TWI241345B (en) 2000-03-10 2005-10-11 Chugai Pharmaceutical Co Ltd Apoptosis inducing polypeptide
JP5485489B2 (ja) 2000-08-11 2014-05-07 中外製薬株式会社 抗体含有安定化製剤
WO2002033072A1 (fr) 2000-10-20 2002-04-25 Chugai Seiyaku Kabushiki Kaisha Anticorps degrade, agoniste de tpo
JP5052736B2 (ja) 2001-05-30 2012-10-17 中外製薬株式会社 タンパク質製剤
CN101721362B (zh) * 2002-02-14 2018-07-03 中外制药株式会社 包含抗体的溶液制剂
JP4083634B2 (ja) 2002-07-11 2008-04-30 旭化成ファーマ株式会社 光に安定なカルシトニン水溶液
JP3976257B2 (ja) 2002-09-17 2007-09-12 栄研化学株式会社 蛋白質の安定化方法
US20050158303A1 (en) 2003-04-04 2005-07-21 Genentech, Inc. Methods of treating IgE-mediated disorders comprising the administration of high concentration anti-IgE antibody formulations
DE602004030451D1 (de) 2003-07-15 2011-01-20 Chugai Pharmaceutical Co Ltd Produktion von igm durch transformierte zellen und verfahren zur quantifizierung dieser igm-produktion
KR101367544B1 (ko) 2005-06-10 2014-02-26 추가이 세이야쿠 가부시키가이샤 메글루민을 함유하는 단백질 제제의 안정화제, 및 그의이용
BRPI0620316A2 (pt) 2005-12-21 2011-11-08 Wyeth Corp formulações de proteìnas com viscosidades reduzida e seus usos
CA2638811A1 (en) 2006-02-03 2007-08-16 Medimmune, Llc Protein formulations
CN104761637B (zh) 2006-03-31 2021-10-15 中外制药株式会社 调控抗体血液动力学的方法
JP2007332093A (ja) 2006-06-16 2007-12-27 Apro Life Science Institute Inc タンパク質のリフォールディング添加剤及びそれを用いたタンパク質の再生方法
CA2674608A1 (en) 2007-01-09 2008-07-17 Wyeth Anti-il-13 antibody formulations and uses thereof
CA2682292A1 (en) 2007-03-30 2008-10-09 Medimmune, Llc Aqueous formulation comprising an anti-human interferon alpha antibody
JP5119545B2 (ja) * 2007-06-19 2013-01-16 国立大学法人 筑波大学 蛋白質を含む液状組成物中における蛋白質の安定化方法
KR101680906B1 (ko) 2007-09-26 2016-11-30 추가이 세이야쿠 가부시키가이샤 항체 정상영역 개변체
MX2010003329A (es) 2007-09-26 2010-04-27 Chugai Pharmaceutical Co Ltd Anticuerpo anti-receptor de il-6.
TW201634479A (zh) 2007-12-05 2016-10-01 中外製藥股份有限公司 抗ｎｒ１０抗體及其應用
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
WO2009104369A1 (ja) 2008-02-22 2009-08-27 パナソニック株式会社 血漿に含まれる成分の検出方法ならびにそれに用いられる試薬および検出デバイス
AR080428A1 (es) * 2010-01-20 2012-04-11 Chugai Pharmaceutical Co Ltd Formulaciones liquidas estabilizadas contentivas de anticuerpos
BR112012027828A2 (pt) 2010-05-03 2016-08-09 Genentech Inc composição de matéria, artigo de fabricação e método de redução da viscosidade de uma formulação contendo proteína e de preparação de uma formulação aquosa contendo proteína
WO2013012022A1 (ja) 2011-07-19 2013-01-24 中外製薬株式会社 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤

Also Published As

Publication number Publication date
EP2735315A1 (en) 2014-05-28
WO2013012022A1 (ja) 2013-01-24
US10898572B2 (en) 2021-01-26
EP2735315B1 (en) 2019-10-02
JP2017222654A (ja) 2017-12-21
JP6469765B2 (ja) 2019-02-13
US20170112930A1 (en) 2017-04-27
EP2735315A4 (en) 2014-12-24
JPWO2013012022A1 (ja) 2015-02-23
US9574005B2 (en) 2017-02-21
US20140206845A1 (en) 2014-07-24

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